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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Study Status Progress Adequate
Application Number P980040 S058/ PAS001
Date Current Protocol Accepted 03/03/2017
Study Name ECR IOL PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21

ECR IOL PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 01/29/2016 01/29/2016 On Time
one year report 07/30/2016 07/28/2016 On Time
18 month report 01/28/2017 01/23/2017 On Time
two year report 07/30/2017 09/07/2017 Overdue/Received
three year report 07/30/2018 07/26/2018 On Time
four year report 07/30/2019    
five year report 07/29/2020    

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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